A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds

Obesity, Childhood Clinical Trial

Official title:

A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds - a Randomised Controlled Trial in Primary Child Health Care.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147039
• Other study ID #: 2019-02747
• Status: Completed
• Phase: N/A
• Start date: November 2, 2019
• Est. completion date: April 8, 2022

Study information

• Verified date: July 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Childhood obesity is still a major global health issue. The preschool age (2-5 years) has been identified as a critical period to intervene, Mobile technology (mHealth) has been successful for weight loss and behavior changes in adults. This proposed randomized controlled trial aims to assess the effectiveness of an 6-month intervention program, the Mobile-based intervention to stop obesity in preschoolers (MINISTOP) 2.0 mobile phone app integrated in primary child health care for parents of children aged 2.5 years. The MINISTOP 2.0 app is built on the previous MINISTOP 1.0 app. Five hundred children will be recruited at their routine visit at 2.5 years of age and after baseline measures randomized to the intervention or control group. In addition, the investigators will assess acceptability, feasibility and appropriateness of the app by parents and primary child health care nurses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months to 38 Months

Eligibility

Inclusion criteria:

-Children at the routine visit at 2.5-3 years of age at selected primary child health centers in Sweden

Exclusion criteria:

• Children diagnosed with neurological or endocrine diseases

• Children who have a parent suffering from a serious physical or psychological disease making the study too demanding for the family

• Children from families who will not be able to understand the content of the app (i.e. do not speak Swedish, English, Somali or Arabic)

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• MINISTOP 2.0
The MINISTOP 2.0 is a behavioural change program aiming to promote healthier diet and physical activity among 2.5-year-old children. The program consists of features such as information, monitoring and feedback (dietary key variables, physical activity, screen time) and it is built around 13 themes during the 6-month period.

Locations

Country	Name	City	State
Sweden	Department of Biosciences and Nutrition, Karolinska Institute	Huddinge
Sweden	Linköping University	Linköping

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Forte

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intake of dietary key indicators as assessed by a questionnaire	Intake of dietary indicators such as fruits and vegetables, sweet and savory treats, sugar-sweetened drinks (in portions or grams per day)	At the end of the intervention which is six months after baseline
Primary	Physical activity as assessed by a questionnaire	Time spent on moderate-to-vigorous physical activity, screen time (min/day)	At the end of the intervention which is six months after baseline
Secondary	Body mass index	Body weight divided by squared height	At the end of the intervention which is six months after baseline
Secondary	Satisfaction and usage of the app as assessed by a questionnaire and interviews	Percentage of users (parents and primary health care nurses) that were satisfied with app, used features in the app	At the end of the intervention which is six months after baseline
Secondary	Usage of the app as assessed using the objectively measured activity in the app	Number of recordings and messages read in the app (per time unit such as per week)	At the end of the intervention which is six months after baseline
Secondary	Parental self-efficacy to promote healthy diet and physical activity behaviors in their child as assessed by a questionnaire	Derived scores from selected questions from a questionnaire (Parental Self-Efficacy for Promoting Healthy Physical Activity and Dietary Behaviors in Children Scale (PSEPAD) Questionnaire). The minimum value is 0 and the maximum value 10.	At the end of the intervention which is six months after baseline